Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 (paradigm™ 4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395810
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Results Submitted - Not Posted on
Results information has been submitted to by the sponsor or investigator, but is not yet publicly available (or "posted") on The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
  Recruitment Status : Completed
  Actual Primary Completion Date : March 31, 2014
  Actual Study Completion Date : March 31, 2014
  Certification/Extension First Submitted : November 9, 2016

Submission Cycle Results Submitted to Results Returned after Quality Control Review
1 November 28, 2017 December 20, 2017
2 April 9, 2018  
Publications of Results:
Other Publications:
Young G, Collins P, Tehranchi R, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten E, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Zak M, Abdul Karim F. Safety and efficacy of nonacog beta pegol (N9-GP) for prophylaxis and treatment of bleeding episodes in previously-treated patients with hemophilia B: results from an extension trial. American Society of Hematology - 56th Annual Meeting (ASH) in San Francisco, CA, US